Frequently asked questions
Q1. What is a clinical study/trial?
As with new medications for people, new animal drugs must be tested for safety and effectiveness. This specific study is regulated by the U.S. Food and Drug Administration in order to evaluate a potential new medication for dogs with Stage B2 MMVD.
Q2. Which dogs are eligible for this study?
- Have been diagnosed by a veterinarian with a heart murmur and enlarged heart, known as Stage B2 MMVD
- Be at least 6 years of age
- Not be pregnant or lactating
- Weigh between 9 and 33.1 pounds
- Meet certain other medical criteria as outlined here
Q3. What are the benefits of participating?
- Everything required by the study is free, including:
- A full year of specialty care from a veterinary cardiologist
- Radiographs (x-rays)
- Echocardiogram (ultrasound of the heart)
- Physical exams
- Investigational medication
- All dogs will receive the actual investigational medication–not a placebo
- Owners of dogs who complete the study will receive up to $500 to spend on goods and services at their referring primary care veterinarian’s hospital
- The study may benefit other dogs in the future and will help advance veterinary science
Q4. If I enroll my dog, what are my responsibilities?
- Give your dog the flavored chewable medication twice per day, every 12 hours
- Periodically measure your dog’s resting respiratory rate (The study site will show you how to do this)
- Keep an electronic dosing log indicating when you give the test medication
- Report observations on how your dog is doing
- Not board your dog (if at all possible) during the study
- Not schedule any voluntary procedures (such as dental cleaning) for your dog during the study
- Keep your dog on the study for up to a full 365 days
- Visit the investigator hospital approximately 10 times during the year, four times with your dog, and six times with or without your dog
Once your dog is enrolled, be certain to complete this short post-enrollment form to ensure you receive clinic credits paid to your primary care veterinary hospital.
Q5. How do I get started?
Dogs must be referred to the study by a veterinarian. Start by discussing the study with your primary care veterinarian, who can find the information needed on this website on the Veterinarian page.
If your dog is determined to be eligible to be screened, you and your veterinarian will be contacted, and you will be asked to schedule your dog for a screening visit with the participating veterinary cardiologist in your area.
Q6. Are all clinical studies/trials regulated by the U.S. Food and Drug Administration?
No, and it is always wise to ask before enrolling your pet. The FDA is the government agency that is concerned with the effects of foods, drugs, and cosmetics on humans and animals. Before a new animal drug can be approved, it must undergo extensive safety and effectiveness testing, just like new medications for humans. Clinical studies regulated by the FDA must be conducted according to strict protocols that ensure consistent procedures are followed at each study site.
Q7. Are there any risks involved to my dog?
As with all medications, there are risks and benefits. The clinical investigator (veterinary cardiologist) will review these with you at your dog’s preliminary evaluation.
The investigational medication in this study is currently licensed to treat dogs with clinical signs of congestive heart failure (CHF), and this study is evaluating the medication’s safety and effectiveness when used at an earlier stage, prior to the development of clinical signs.
Q8. Are there any costs involved?
Q9. Who is paying for the study?
Q10. How many times will I need to go to the investigator’s hospital?
During the possible 365 days of the study, approximately 10 visits to the veterinary cardiologist’s hospital are required. You will need to take your dog to four of these visits, and you can go with or without your dog to the other six.
Q11. How long does the study last?
Eligible dogs participate for up to 365 days.
Q12. What if I enroll my dog and then decide I no longer wish to participate?
We hope that owners will keep their dogs enrolled in the study for the entire duration, but you may opt out of the study at any time.
Q13. I’m interested in enrolling my dog in this study. What steps should I take to do so?
If your dog has been diagnosed with Stage B2 MMVD, and there’s a participating veterinary cardiology hospital near you, simply let your primary care veterinarian know of your interest and request a referral.
Q14. Can my dog take other medications while in the study?
Most heart medications (such as ACE inhibitors) and some other drugs are prohibited during the study. If possible, do not begin giving your dog any new medication before talking to your veterinarian about excluded drugs (the full list is on this page). All dogs in the study receive the test medication, so there is no chance your dog will go untreated.